Industry appreciates CDSCO notice to address issues but appeals to authorities to ensure proper mechanism and transition time to comply
Medical Technology Association of India (MTaI) welcomed CDSCO notice GSR 754 (E)simplifying sale license requirements for retailers and wholesalers who are involved in stock or sale of medical devices by also allowing registration certificate in its lieu. The association which represents a significant portion of the contact lens industry, also pointed out that the simplified sale license requirements are well intended but expressed concerns regarding their on-ground implementation.
Pavan Choudary, Chairman & Director General, MTaI, said, “Contact lenses & lens care products are being sold for several decades in the country outside of a sale license requirement in optical stores and contact lens clinics. The new sales license rules though welcome, would mean that thousands of these optical shops now need to go through this mechanism for registration. Most of these units are not aware of thesales license requirement and the process to get the registration certificate. This has disrupted the contact lens business”.
“While we appreciate the simplification of the sale license requirements to ensure adherence to quality and safety, there are several hurdles which its implementation is facing-
- Lack of awareness among optical stores and contact lens clinics regarding sale license/ registration certification requirements
- Lack of preparedness among the regulators for implementation of due process-
- Several State Licensing Authorities, Zone officers and other relevant authorities are yet to be fully sensitized to this registration certificate requirement
- The prescribed process which requires uploading of registration form is not currently available on the portal nor does it have in place an uploading mechanism
- Challenges related to submission of application due to wide geographical spread of optical stores and contact lens clinics across the country- In absence of an online mechanism to apply for registration, the retailers in upcountry/smaller towns will have to travel to their respective State Licensing Authority (SLA) where authorities may not be ready to receive it or process the additional load.
MTaI has apprised the Central Drugs Standard Control Organization (CDSCO) regarding theseissues and look forward to their urgent intervention for a resolution of the same”, added Choudary.
Sanjay Bhutani, Managing Director, Bausch & Lomb India, said, “The most impacted will be the youngsters with active lifestyles who rely on contact lenses for their day-to-day activities. There are more than twenty thousand powers in contact lens based on physiology of the eye, 95 per cent of these powers are not stocked by retail stores and optometrists. As a practice, the retail store orders the required power from the distributors and provide it to the patient. With the new registration/sales license process in effect from October 1, the optical stores are already facing challenges as they are unable to provide contact lens to patients. The implications of regulations will be even more for the patients with ‘Astigmatism’ who requiretoric-lenses.”
“Till the mechanism is ready for implementation of GSR 754 (E), we request the CDSCO to urgently provide extension for theimplementation of sale license or registration certificate requirements for contact lenses and lens care products. As most of the optical shops and contact lens clinic are included in the registration process for the first time, they need sufficient time to understand the regulations and take the necessary approvals. Therefore, a transition time of 5-6 months should be provided to ensure smooth compliance”, appealed Bhutani.
